NCT02170012

Brief Summary

The purpose of this study in healthy elderly people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649- The pharmacodynamic activity of PF-06743649 will also be assessed.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

June 19, 2014

Last Update Submit

March 16, 2015

Conditions

Healthy Elderly

Keywords

Multiple dosesafetytolerabilityPK

Outcome Measures

Primary Outcomes (7)

  • Maximum Observed Plasma Concentration (Cmax)

    up to 14 days

  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

    up to 14 days

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    up to 14 days

  • Plasma Decay Half-Life (t1/2)

    up to 14 days

  • Amount of drug recovered unchanged in urine during the dosing interval (Aetau)

    up to 14 days

  • Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)

    up to 14 days

  • Renal clearance (CLr)

    up to 14 days

Secondary Outcomes (5)

  • Change from baseline in serum uric acid level

    up to 14 days

  • Change from baseline in serum levels of xanthine and hypoxanthine

    up to 14 days

  • Urinary uric acid levels

    up to 14 days

  • Urinary xanthine levels

    up to 14 days

  • Urinary hypoxanthine levels

    up to 14 days

Study Arms (5)

Cohort 1-PF-06743649 or placebo

EXPERIMENTAL
Drug: PF-06743649Drug: Placebo

Cohort 2-PF-06743649 or placebo

EXPERIMENTAL
Drug: PF-06743649Drug: Placebo

Cohort 3-PF-06743649 or placebo

EXPERIMENTAL
Drug: PF-06743649Drug: Placebo

Cohort 4-PF-06743649 or placebo

EXPERIMENTAL
Drug: PF-06743649Drug: Placebo

Cohort 5-PF-06743649 or placebo

EXPERIMENTAL
Drug: PF-06743649Drug: Placebo

Interventions

PF-06743649DRUG

20 mg tablet once daily dosing for 14 days

Cohort 1-PF-06743649 or placebo
PlaceboDRUG

Placebo tablet once daily dosing for 14 days

Cohort 1-PF-06743649 or placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 65 and 85 years, inclusive. Ideally at least 25% of the subjects enrolled in each cohort will be 75 years of age and above at Screening. Subjects must be healthy as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory test results. Subjects with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the investigator.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Evidence of gout/hyperuricemia, measured sUA \>8 mg/dL at screening.
  • Experienced an episode of nephrolithiasis or ureterolithiasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miami Research Associates, Inc.

South Miami, Florida, 33143, United States

Location

MRA Clinical Research, LLC

South Miami, Florida, 33143, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 23, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(2)